A Phase II Extension of a Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients with Chronic Kidney Disease who are on Hemodialysis.
- Conditions
- Anemia in patients with Chronic kidney disease (CKD)
- Registration Number
- EUCTR2009-016376-76-BG
- Lead Sponsor
- Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Patients must meet each of the following criteria to participate in the extension study:
Patient met all entry criteria for MK-2578 in the base study (Protocol 003) and completed the base study per-protocol through Visit 18 (Treatment Week 12)
Patient tolerated MK-2578 and, in the opinion of the investigator and clinical monitor, demonstrated compliance with study procedures.
Patient agrees to commit to the visit schedule required over the entire 40 weeks of this extension study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients are excluded from participating in the extension study if they meet any of the following criteria:
Patient has developed any medicial condition or disorder during the base study that, in the opinion of the investigator or Clinical Monitor, might pose a risk to the patient.
Note: Patients whose dose of MK-2578 remained on hold at the time of completion of the base study, due to Hb values =14.0 g/dL, are eligible to enter this extension. Furthermore, patients in the base study who experienced a serious adverse event that did not disqualify them from the base study are eligible to enroll in this extension; in these cases, the investigators should use their discretion in determining eligibility.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the overall safety and tolerability of intravenous administration of MK-2578 in a 40-week extension study.;Secondary Objective: To assess the efficacy of MK-2578 administered QW and QM and the distribution of MK-2578 doses used during the evaluation period (Weeks 44 to 52) in a 40-week extension study.<br><br>To assess the effect of two titration algorithms on the maintenance of Hb in a 40-week extension study.;Primary end point(s): A high percentage of patients acheive and maintain an HB concentration within 10.0 to 12.0 g/dL(or 11.0 to 12.0 g/dL) during the evaluation period.
- Secondary Outcome Measures
Name Time Method